Roche Tries To Bar Expert Witness In Accutane Trial

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accutaneA federal appeals court will soon decide whether to allow testimony from an expert witness who sought to show that the Accutane acne med causes a chronic bowel disorder, the Associated Press writes.

Yesterday, attorneys urged a three-judge panel to admit the testimony from the expert, which is central to their argument that the prescription drug causes inflammatory bowel disease. For its part, Roche contends Accutane is not connected to the disease and that the expert made “leaps of faith” in trying to track a connection between the two.

The case is the latest in a wave of lawsuits that accuse Roche of downplaying a link between Accutane and inflammatory bowel disease. Plaintiffs lawyers have already won a trio of multi-million dollar jury awards, and they say they have hundreds of other patients with similar cases.

The lawsuit was filed in August 2003 by Justin Rand, who alleged Accutane caused his inflammatory bowel disease. Eight other lawsuits were consolidated into one case in November 2004 and each asks a jury to award unspecified damages.

Their case hinged on testimony from Ronald Fogel, a Michigan gastroenterologist who was the chief expert witness for the plaintiffs. He championed tests he hoped would establish a “reliable foundation” linking the drug and the disease, the AP reports.

US District Judge James Moody tossed out his testimony, though, questioning the methodology of the tests. Roche, the AP writes, eagerly backed the ruling up, charging the doctor with “cobbling together a hodge-podge of individually unreliable and insufficient lines of evidence.”

At Tuesday’s hearing, Rand’s attorneys pressed a three-judge panel to admit the evidence. Taken on a one-by-one basis, the tests alone don’t prove the drug caused the disease, J. Nixon Daniel, a plaintiff’s attorney, acknowledged, but taken together, he said they could. “This method is appropriate regardless of whether Judge Moody agreed with the conclusion,” Nixon said.

Roche, which said some 12 million patients have used Accutane, posts labels on the drug that warn it is “associated with” inflammatory bowel disease. But it has long contended the medicine does not cause the stomach disorder. “Accutane has been on the market for 25 years,” said Paul Schmidt, Roche’s attorney. “We believe the evidence shows already that there is no link. If there was, it would already have been studied.”

The pill has been on the market since 1982. It became a generic drug in 2002 and is sold by three other drugmakers. It has remained on the market through the lawsuits, which are becoming a familiar fight for the company.

Mike Hook, a Florida attorney representing Rand, tells the AP he works virtually full-time representing some 500 people who face similar problems. He has won three cases already, including a jury award of $10.5 million for a Utah woman who used Accutane. Roche appealed two of the decisions and will likely appeal the third.

“There’s so many people out there that have developed inflammatory bowel disease after using Accutane, and these kids needed someone to represent them,” Hook tells the AP. “And I’m going to continue to fight for them as long as I can. We’re seeking justice.”

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